Senate to Finish FDA User Fee Reauthorization Bill Ahead of Summer Recess

Posted 01 August 2017 By Zachary Brennan

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Majority Leader Mitch McConnell (R-KY) said Tuesday that the Senate will follow its House counterparts and vote on the US Food and Drug Administration (FDA) user fee reauthorization bill before heading to recess at the end of next week.

McConnell called to renew the user fee programs as they are “critical to speeding up the drug approval process, and that’s important for everyone frustrated by the time and cost of bringing lifesaving drugs to market. Without it, the important work of ensuring that drugs and devices are safe and effective would come to a screeching halt.”

The comments come as FDA last week pushed back its 1 August deadline by which it had initially said it would need to have the user fees reauthorized by Congress or else it would send layoff notices to thousands of employees.

The US House of Representatives passed its version of the bill via voice vote on 12 July.

By comparison, on 9 July 2012, President Barack Obama signed into law the last reauthorization of the user fee programs, known as the Food and Drug Administration Safety and Innovation Act (FDASIA).

President Donald Trump urged Congress in July to overhaul the agreements forged by FDA and industry, and entirely fund the agency with user fees. Such an overhaul, first discussed in Trump’s budget proposal in May, has been rejected by members on both sides of the aisle, though it remains unclear if Trump would veto the bill if Congress does not accept his proposal.

White House spokesman Ninio Fetalvo told Focus to check with the Office of Management and Budget (OMB) as they “are the ones who publish Statements of Administration Policy.” OMB did not respond to a request for comment.

Other Bills on Drug Prices

In addition to the user fee reauthorization, Sen. Amy Klobuchar (D-MN) introduced legislation on Tuesday that would allow for Medicare to improve the process by which it negotiates prices for seniors enrolled in Medicare Part D. 

“Medicare is one of the largest drug purchasers in the country. It makes no sense that it’s restricted from negotiating the best deal with drug manufacturers,” Klobuchar said.

In addition, Sen. Bernie Sanders (D-VT) introduced an amendment to the Federal Food, Drug and Cosmetic Act of 1938 that would require federal agencies and federally funded nonprofits to secure reasonable pricing agreements from manufacturers before they grant exclusive rights to companies that make drugs, vaccines or other health care products.

And the Congressional Budget Office (CBO) on Monday unveiled its preliminary cost estimate for another Sanders bill to allow for less expensive prescription drug imports from Canada. CBO said the bill would save the federal government more than $6 billion over 10 years.

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, News, US, FDA

Tags: FDA user fees, BsUFA, GDUFA, PDUFA, MDUFA, drug prices, Medicare

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